Course Description

Writing Effective Regulatory, Medical and Technical Documents

October 21-22, 2019
Edison, NJ

Course Offering 191021NJ0162
Course ID 162

In-Person Course

Who Should Attend?
This course will benefit professionals from new hires to managers in the pharmaceutical, medical device, biologics and related health industries
who would like to write more effective documents. It is a valuable course for
those in:
  • Clinical Research
  • Product Development
  • Regulatory
  • QA/QC
  • Compliance
  • Manufacturing
  • Engineers/Scientists
  • Directors and Managers
  • New Hires

Course Description
Writing accurate, concise, and clear technical documents is critical for a company’s successful interaction with the FDA and other regulatory bodies. Effective writing is a skill that must be constantly refined to produce these quality documents.

This practical two-day accredited course will teach you methods to evaluate your writing style and apply steps to express complex ideas more clearly and concisely. Through lectures and class exercises you will learn strategies for organizing, revising, editing, and proofing documents and correspondences. Essential elements of technical report sections will also be discussed as well as how to respond to FDA requests for information.

Course Director
Zeinab Schwen, President, Strategic Regulatory Consulting

Zeinab Schwen has over 38 years of experience in the pharmaceutical and medical device industries. After working for major pharmaceutical companies, she founded a successful consulting and medical communications company which has been supporting the health care industry for over 27 years. In her capacity as the President of Strategic Regulatory Consulting she has provided product development, regulatory consulting, submission assistance, and medical communications services to companies nationwide. Ms. Schwen has also taught at several Universities and has led numerous regional workshops on medical, technical, and regulatory writing.

Venue Information
venue
ExitCertified (MicroTek partner facility)
Raritan Plaza III
105 Fieldcrest Avenue, Suite 405
Edison , New Jersey 08837
Phone: 800-207-9620 (for directions and parking info only)

PLEASE NOTE: Participants must make their own reservations; the cost of hotel accommodation is not included in the course fee. Final hotel information will be emailed to you in your confirmation package approximately 3 weeks prior to the course start date.

Directions: Visit the Hotel Venue topic on our FAQ page.